| CTRI Number |
CTRI/2025/07/090119 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparision between block characteristics of intrathecal hyperbaric bupivacaine and hyperbaric levobupivacaine in surgeries below umbilicus |
|
Scientific Title of Study
|
A comparision between block characteristics of intrathecal hyperbaric bupivacaine versus hyperbaric levobupivacaine in patients undergoing infraumbilical surgeries a randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nabanita Debnath |
| Designation |
PG trainee |
| Affiliation |
Regional institute of medical science ,Imphal |
| Address |
Dept of Anaesthesiology,
Regional institute of medical science, Imphal, Manipur,India
Imphal West
MANIPUR
795004
India |
| Phone |
7005442623 |
| Fax |
|
| Email |
debnathn783@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gojendra Rajkumar |
| Designation |
HOD & Associate Professor |
| Affiliation |
Regional institute of medical science,Imphal |
| Address |
Dept of Anaesthesiology,
Regional institute of medical science, Imphal, Manipur,India
Imphal West
MANIPUR
795004
India |
| Phone |
7005442623 |
| Fax |
|
| Email |
gojendrar68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nabanita Debnath |
| Designation |
PG trainee |
| Affiliation |
Regional institute of medical science,Imphal |
| Address |
Dept of Anaesthesiology,
Regional institute of medical science, Imphal, Manipur,India
Imphal East
MANIPUR
795004
India |
| Phone |
7005442623 |
| Fax |
|
| Email |
debnathn783@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,Regional Institute of Medical Science, Imphal(west),Manipur, India pin-795004 |
|
|
Primary Sponsor
|
| Name |
Dr Nabanita Debnath |
| Address |
Department of anesthesiology,
Regional institute of medical science, Manipur, Imphal (west), pin-795004 |
| Type of Sponsor |
Other [post graduate trainee] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nabanita Debnath |
Regional Institute of Medical Science |
Oparation Theatre of RIMS,Department of Anaesthesia,Imphal West,Manipur
Imphal West
MANIPUR |
7005442623
debnathn783@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board,RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj Bupivacaine heavy |
Study participants will be randomized into two groups. One group will receive 3 ml Inj Bupivacaine heavy intrathecally before infraumbilical surgery starts and we will record the block characteristics and heamodynamic changes of the patients every 2 mins for first 10 mins, every 5 mins for next 20 mins and every 10 mins until surgery gets over. |
| Comparator Agent |
Inj Levobupivacaine Heavy |
Study participants will be randomized into two groups. One group will receive 3 ml Inj Bupivacaine heavy intrathecally before infraumbilical surgery starts and we will record the block characteristics and heamodynamic changes of the patients every 2 mins for first 10 mins, every 5 mins for next 20 mins and every 10 mins until surgery gets over. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled to undergo elective infraumbilical surgeries under spinal anaesthesia with the following criteria will be enrolled:
Age:18 to 60 years
Gender: male and female gender,
Details:American Society of Anaesthesiologist (ASA) physical status I & II. |
|
| ExclusionCriteria |
| Details |
Patients with the following criteria will be excluded-1.refuse to give consent 2.infection at the site 3.spinal deformity 3.history of allergy to study drugs 4.Patient on anticoagulant and antiplatelate 5.uncontrolled hypertension, diabetes mallitus,respiratory system disease,kidney disease 6.psychiatric patient 7.pregnant women 8.Patient undergoing emergency surgeries 9. weight less than 45 and more than 110 10.height less than 140cm and more than 180cm. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Motor and sensory block characteristics |
We will record time of onset of motor block,duration and regression of motor block.
For sensory block,we will record time of onset of sensory block and level of sensory block every 2 mins uptil 10 mins,every 5 minutes uptil 30 mins then every 10 minutes uptil closure of operative site as well as time of 2 segments regression of sensory block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heamodynamic changes & any adverse outcome |
We will measure heart rate,systolic blood pressure, diastolic blood pressure & mean arterial pressure for heamodynamic changes every 2 mins for 1st 10 mins, every 5 mins for next 20 mins ,every 10 mins until the surgery gets over & nausea,vomiting as adverse effects intraoperatively. |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intrathecal anaesthesia is a type of neuraxial anaesthesia in which reversible blocking of nerve stimulus transmission is done by injecting local anaesthetics agents into subarachnoid space. It has advantages in cases where the airway approach is difficult as well as over the depressive effects on different systems by the agents used in general anaesthesia, also it is comparatively easy and safe technique. It has become popular technique for various infraumbilical surgeries like caesarean section, hernia operation, perineal surgeries, lower limb surgeries, lumber spine surgeries, urological surgeries etc.This study will be a Randomized controlled double blinded study to compare the block characteristics of hyperbaric bupivacaine and hyperbaric levobupivacaine in infraumbilical surgeries under spinal anaesthesia. A total number of 130 patients aged 18-60 years of male and female gender, ASA physical status I and II who will be undergoing infraumbilical surgeries surgeries shall be enrolled in the study. The patients will be divided into two groups of 65 each. The study drug will be prepared in a 5ml syringe by an anaesthesiologist not directly involved in the study to keep the study double blinded. Group B will receive 3 ml 0.5% hyperbaric bupivacaine, Group L will receive 3ml 0.5% hyperbaric levo bupivacaine. The operating room temperature will be maintained at an ambient temperature of around 24oC to 26oC. Vitals parameters like temperature, blood pressure, heart rate, SpO2 will be recorded preoperatively and intraoperatively. Time of onset of motor and sensory block ,its duration and time of regression will be recorded along with hemodynamic parameters and side effects.In case bradycardia will be defined as heart rate less than 50 beats per min and will be treated with 0.6mg Atropin IV whereas hypotension will be defined as decrease in systolic blood pressure more than 30% from the baseline and is treated with IV bolus of ringer lactate solution @15ml/kg over 15 mins and if not responded then IV inj Mephentermine 6mg IV should be injected. Fluids will be administered to replace intraoperative losses. The data collected will be analysed and interpreted by appropriate statistical method. Quantitative data will be analysed using Students t test and qualititative data will be analysed using Chi square test. P value <0.05 will be taken as significant. |